CAPSTONE Spinal System, CLYDESDALE Spinal System

CAPSTONE Spinal System, CLYDESDALE Spinal System is an FDA 510(k)-cleared medical device (K151128) manufactured by Medtronic Sofamor Danek USA, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 5, 2015. Regulation: 8.